Mobile intra-operative microscopic diagnosis laboratory

ABSTRACT

A mobile intra-operative microscopic diagnosis laboratory capable of analyzing fresh tissue specimens and providing intra-operative consultation within 20 minutes is described. The mobile laboratory is preferably a van and contains a cryostat for freezing the fresh tissue specimens and a means for cutting the specimens. In addition, it also contains the means for reading the slides to make microscopic diagnosis and a means for handling for fresh tissue and a means for indicating various locations in the specimen, preferably by inking them. It preferably contains a stainer for staining the samples and an intercom for communicating the microscopic diagnosis back to the operating room.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a mobile laboratory to provide intra-operativemicroscopic diagnosis.

2. Description of Prior Art

Traditionally invasive procedures (surgeries, CAT scan directedbiopsies, etc.) requiring intra-operative consultation (IOC) from apathologist, are taken to the hospital, even if these can be performedin physicians' offices. This is because, hospitals where most invasiveprocedures are performed, are where pathology practices are centered.Typically physicians' offices and small surgery centers would not havethe services of a pathologist available for IOC. There is a need for IOCto be available for small surgery centers and to physicians' offices.Currently, once a fresh tissue specimen is taken from the patient if thesurgery is performed in a physicians' office or in a small surgerycenter, then the surgery must be halted until the analysis of the freshtissue specimen can be completed. This would typically involvetransportation to a hospital where pathologist services are availableand could either take hours or sometime the continuation of the surgeryis rescheduled for a later day.

Providing mobile ambulatory surgical centers such as those disclosed inU.S. Pat. No. 6,082,799 are known and performing freezing operations ina vehicle are also well known. However, none of the operations or mobilemedical vehicles available are capable of providing intra-operativemicroscopic diagnosis capable of analyzing fresh tissue specimens andproviding intra-operative consultation within twenty minutes. Given theexploding number of smaller surgical procedures being performed outsidehospitals, the need for such a method and vehicle for providing suchdiagnosis. The object of this invention is to provide a method andmobile laboratory capable of being utilized to analyze fresh tissuespecimens and providing intra-operative consultation within twentyminutes. It is the further object of this advantage to do so in a mannerthat complies with all OSHA and Clinical Laboratory Improvements Act of1988 (CLIA) Requirements for the handling of tissue specimens.

SUMMARY OF THE INVENTION

The present invention includes a Mobile Intra-Operative MicroscopicDiagnosis Laboratory capable of being utilized to analyze fresh tissuespecimens and provide intra-operative consultation within twentyminutes. The laboratory is mobile and while preferably a van, includesany means for transporting said laboratory from location to location. Inhandling the fresh tissue specimens it is necessary to have a means forfreezing said fresh tissue specimens. Currently the preferable way offreezing the fresh tissue specimens is with a cryostat. It is alsonecessary to have a means within said laboratory for reading slides tomake a microscopic diagnosis, typically utilizing a microscope. It isvery important that there be sufficient means within said laboratory forhandling the fresh tissue specimens. Typically they would be handledwith non-porous gloves and the surfaces the fresh tissue specimens areon would be non-porous surfaces. There would also need to be a means todispose of all the fresh tissue specimens and contaminated material,which would include biohazardous waste disposal and would also includegloves, masks, plastic aprons, etc. pursuant to OSHA Regulations. Allthe operations within said laboratory would be covered by the ClinicalLaboratories Improvements Act of 1988 which governs the handling offresh tissue specimens.

There would need to be a means within said laboratory for indicating thevarious locations in fresh tissue specimens and this would preferably beby inking said tissue specimens. It would also be necessary for there tobe a means within the laboratory for dissecting the fresh tissuespecimens and this would typically include cutting with a knife, bladeor scalpel. The preferred way would be as shown in the drawings by useof a special knife within the cryostat so that after freezing the tissuespecimens could be cut to some very thin thicknesses (4-5 micronsthick). After the fresh tissue specimen is frozen it is preferable tohave a means within said laboratory for histological staining of thespecimen. It is also preferable within said laboratory for means forcommunicating microscopic diagnosis to an outside entity, for example anintercom system with a wireless connection directly to the operatingroom.

The present invention further includes a method for analyzing freshtissue specimens and providing intra-operative consultation withintwenty minutes within a Mobile Intra-Operative Microscopic DiagnosisLaboratory, when the laboratory can be transported from location tolocation. Included are handling the fresh tissue specimens, makingmicroscopic diagnosis, indicating various locations in the fresh tissuespecimens, dissecting said specimens, freezing said specimens, andidentifying each specimen by giving it a unique number. It is alsonecessary to provide heating and cooling within the laboratory withoutcreating unnecessary vibration so that the pathologist within thelaboratory can read the specimens. It is further preferable to have anautomatic stainer within the laboratory for staining of the fresh tissuespecimens after being frozen.

MICS (mobile intra-operative consultation service) facilitatesdisconnecting the surgeries connected to the hospitals by IOC. In theprocess it helps the changing paradigm of reducing health care costs,improving community based healthcare services and patient convenience.In this changing paradigm of striving to decrease healthcare costs, someof the more expensive hospital based services have begun to beoutsourced (generic drugs, home-health care, alternative medicine, birthcenters, non-physician healthcare providers, minor invasive procedures,etc.) Three of these are centered around services provided by thepathologists.

The most important of the latter relates to the surgeries that can beperformed in offices and in ambulatory surgery centers (ASCs) which willbe followed by the invasive procedures being performed by radiologistsand will finally lead to office based pathology service for hospitals.

The present invention has adapted resources to provide theintra-operative consultation outside the hospital. MICS is the firstaccredited mobile intra-operative consultation service; it is equippedwith all of the gadgets, the information and the telecommunicationsystem required by various regulatory authorities and is operated understrict SOP. Physicians and patients have the convenience of having minorsurgeries (not major ones requiring open abdominal/thoracic surgeriesand not for high risk patients), which constitute about a third of thehospital surgical volume, to be performed in offices and ASCs. The MICSis driven to the location by the pathologist to provide the requiredintra-operative consultation (diagnosis of a lesion required to directthe further course of action or consultation on complete removal of apreviously diagnosed lesion or providing a means to harvest tissue forhighly specialized studies, etc.) Hospital based surgeries are not onlyexpensive but cause tremendous inconvenience to patients, requiringarrangements for child-care, scheduling time off (paid or unpaid) fromwork or school, etc. MICS addresses both by reducing the cost by over75% and facilitating the convenience of adjusting healthcare to thepatient's daily routine. ASC or office based procedures take much lesstime and can be centered around patient convenience; even over theweekend.

The next step would be to provide the same for the radiologists whoperform biopsies of internal organs by introducing needles under theguidance of a CAT scan. Pathologist will ensure adequacy of the materialobtained by this expensive procedure, which can now be performed inoutpatient radiology facilities. The cost and convenience of thisprocess is similar to the above.

The final step will be complete out sourcing of the pathology services.Most pathologists are based in hospitals mainly to provideintra-operative consultations. Other services provided by thepathologists include postmortem examination, diagnosis on other tissuesremoved and medical directorship of the clinical laboratory. All of thelatter can be provided by on-call pathologists and/or outside thehospital. Traditionally most hospitals employ the pathologists andprovide them with prime-space. With introduction of DRG, laboratoriesare a cost-center (not a revenue center) for hospitals. By out sourcingthe pathology services, pathologists can provide the service on acontract basis and earn most of their income from outpatient surgerieswhich generally do not come to hospitals. This is very economical forhospitals by saving space and not having to employ pathologists.

The MICS provides the passport to the outside world and cuts the cordthat attaches the expensive services to the hospital. It helps thesurgeons and the radiologists to be more efficient and entrepreneurial.It helps the hospitals focus on the major surgeries with betterutilization of their resources during this drought—shortage of healthcare workers. It improves community based pathology service, which isnonexistent at this time. It helps patient morale and economics. It isan important conduit to improved healthcare in America.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a top view schematic of the inside of the van of the presentinvention.

FIG. 2 is an exposed curbside view of the van of the present invention.

FIG. 3 is an exposed driver's side view of the van of the presentinvention.

FIG. 4 a is a front exposed view of the cryostat of the presentinvention.

FIG. 4 b is an exposed view of the inside of the cryostat.

FIG. 4 c is an exposed view of the cryostat knife.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

FIG. 1 is a top view schematic of the inside of the MobileIntra-Operative Microscopic Diagnosis Laboratory. Shown in FIG. 1 is avan 10 which is the most likely means for transporting the laboratory.The best way of explaining the schematic is to describe the process thatthe physician receiving the sample would go through in providing thediagnosis. The sample is typically first received through the window 14which is in the upper portion of the sliding door 12. A fold overcounter top 16 is available to be utilized when the sample is received.The first step after receiving the sample is the grossing step where thesample is measured, described and inked typically at the fold overcounter top or grossing station 16, which is all dictated by thephysician. Next, the sample is placed on the chuck 82, shown in FIG. 4,which is part of the cryostat 24 and then the chuck 82 is placed insidethe cryostat 24. After the sample is frozen within the cryostat 24,microscopic sections of the sample are cut and placed on a slide. Notall, but many samples are then stained in the stainer 28 forapproximately 35 seconds and then the physician takes the sample andplaces it under the microscope 26. After examining the sample under themicroscope 26, the physician then makes the diagnosis and communicatesthe diagnosis with the surgeon in the operating room. Communication withthe surgeon is preferably by an intercom to the operating room. Thephysician in the operating room will preferably be given one intercomand its mate will be the intercom 32, as shown in FIG. 3, locatedpreferably above the microscope 26. In making the diagnosis, thephysician will preferably use a unique identification number, which iscompiled by entering the Social Security number and date of birth of thepatient, which gives the identification number unique to that particularpatient. After the diagnosis is made and communicated to the operatingphysician, the physician in the laboratory will dictate the diagnosisinto the digital dictation system, which is part of the computer 30 asshown in FIG. 3. A combination printer, fax machine and scanner 60 isprovided near the front of the laboratory as shown.

The Mobile Intra-Operative Microscopic Diagnosis Laboratory shown inFIG. 1 also contains numerous items that aid the pathologist inperforming the tissue analysis. The van must be well lit as shown by thelights 64 at the top of the van. A paper towel holder 52 is placed asshown for the convenience of the physician. Additional curbside storagecabinets 54 are included under the stainer 28 and a counter 56 on top ofthe left battery and a counter 58 on top of the right battery providemore workspace.

Proper air conditioning is critical to maintaining and operating thelaboratory. An earlier design of the present invention included the airconditioning running off the van's diesel engine. The problem was thatthe vibration was so great that the slides could not be read. Thesolution was to put in a separate air conditioning and heating unit thatcooled and heated the lab without running the engine and thus withoutcausing vibration. The air conditioning runs off of the left battery 20and the right battery 22. To recharge the batteries a car plug can beadded outside the van and a generator can sit next to the van providingthe air conditioning and heating. The generator can run on gasoline andbe attached to the back of the van. The roof air conditioning unit 38 isdesigned to produce adequate cooling. There is also a roof vent 42.Additional access and exit points are provided by the rear doors 44 andfront doors 46 as shown in FIG. 1.

FIG. 2 is an exposed curbside view of the van of the present invention.FIG. 2 shows the driver door 48 and then looks through the van to thecurbside looking at the curbside from the perspective of someone insidethe van. The side entry door 12 is the primary means that thepathologist would enter and exit the laboratory. Once entering thelaboratory, the flip-down corner top and grossing station 16 would beset in place which is right below the slider window 14. This window 14is primarily where the tissue samples would be received from. Thegrossing station 16 would be the first operation where the samples arereceived and to the right of the grossing station 16 is the stainer 28.There are extensive batteries necessary for the operation of thelaboratory and shown on the curbside in FIG. 2 is the left battery 20.From the pathologist's view if one were to continue working around thevan clockwise, at the rear of the van would be the cryostat 24 shown inFIG. 1 and FIG. 4.

The driver's side of the van is shown in FIG. 3, and as in FIG. 2, herethe passenger door 50 is shown and we are looking through the van to thedriver's side. Continuing on in clockwise fashion, is the right battery22 and sitting near the top of the van, spatially above the batterywould be the intercom 32. Proceeding next around the van would be themicroscope 26 and next to that would be the computer 30. The computerwould sit on top of the slide storage cabinet 66 and continuing to theright would be the space for additional equipment and the microwave 36.

It is important to maintain proper environmental conditions inside thelaboratory and a combination humidistat, barometer and thermostat 62 isprovided with the van. Additional slide storage 34 is also provided.Additional conveniences such as an angled footrest 70 and a food onlyrefrigerator 68 are provided for the convenience of the pathologistutilizing the laboratory.

FIG. 4 a shows the cryostat 24 and on the exterior of the cryostat thecryostat handle wheel 76, cryostat drainage bottle 72 and the cryostatvent 74. FIG. 4 b is an exposed view of the inside of the cryostat andshows the chuck 82 which the tissue sample is placed on. The chuck 82 isplaced on the chuck holder or freezing chamber 78 which is showntogether with the quick freeze peltier 80. Additionally shown is theheat extractor 84 all of which combine to quickly freeze the tissuesample. Another important part of the cryostat 24 is the knife 86 asshown in FIG. 4 c. The knife must be capable of cutting extremely thinsections of tissue and the physician operates the knife by use of thehandle 88.

1. A mobile intra-operative microscopic diagnosis laboratory capable ofbeing utilized by a pathologist to analyze fresh tissue specimens andprovide intra-operative consultation within twenty minutes comprising:(a) a van containing said laboratory for transporting said laboratory;(b) a countertop within said laboratory, suitable for performinggrossing operations; (c) a chuck within said laboratory for holding saidfresh tissue specimens; (d) a cryostat within said laboratory forplacing said chuck in for freezing said fresh tissue specimen; (e)additional counter space within said laboratory for cutting said frozenfresh tissue samples specimens; (f) a microscope within said laboratorysuitable for making a microscopic diagnosis on said frozen fresh tissuespecimens; (g) lighting within said laboratory suitable for enabling apathologist to analyze said frozen fresh tissue specimens; (h) roofvents within said van; (i) air conditioning units within saidlaboratory; (j) batteries within said van capable of powering said airconditioning units; (k) a humidistat, barometer and thermometer withinsaid laboratory for maintaining proper environmental conditions withinsaid laboratory.
 2. The Mobile Intra-Operative Microscopic DiagnosisLaboratory of claim 1 further comprising means within said laboratoryfor communicating said microscopic diagnosis to an outside entity. 3.The Mobile Intra-Operative Microscopic Diagnosis Laboratory of claim 1further comprising means within said laboratory for histologicalstaining said frozen and dissected fresh tissue specimen before saidspecimen is analyzed.
 4. The Mobile Intra-Operative MicroscopicLaboratory of claim 1 further comprising means to dispose ofcontaminated materials.